Centers for Medicare & Medicaid Services’ decision on drug-coated balloons: No additional reimbursement despite higher cost and highest levels of scientific evidence
Year: 2018
Type: editorial
Abstract: Beyond lifestyle intervention, medical therapy, and supervised exercise, peripheral artery disease (PAD) and its more advanced form, critical limb ischemia (CLI), are commonly treated with endovascular or surgical revascularization.For many years, interventionists commonly used off-label medical devices with little prospective data to guide treatment.Furthermore, professional societies and guidelines struggled to identify class I indications given the paucity of randomized controlled clinical trials.More recently, many third-party payers and the US Food and Drug Administration (FDA) have required 'on-label' indications for use of specific vascular devices.However, these studies have limited follow-up (typically 1 year), are frequently single-arm investigational device exemption (IDE) studies, and lack independent core laboratory adjudication.Fortunately, these realities changed with the introduction of drug-eluting stents (DES) and drug-coated balloons (DCB).DES were first approved in November 2012 and DCB in February 2015.Since then, 5-year data for DES and 4-year data for DCB have been published.Eight randomized controlled trials have shown DCB to be superior to uncoated percutaneous transluminal angioplasty (PTA) in the femoral-popliteal arteries, with improved patency, decreased need for repeat revascularization, and ultimately lower overall healthcare cost.1-3 The Centers for Medicare & Medicaid Services (CMS) recognized the clinical effectiveness of DES and DCB and offered special transitional passthrough (TPT) codes so that these novel, clinically proven therapies would be offered to patients without overriding concerns regarding cost.However, on January 1, 2018 the TPT add-on payment for DCB was terminated without creating a new ambulatory payment classification (APC) rate.Effectively, the CMS bundled DCB with uncoated PTA under the same APC rate, implying that the two devices were 'clinically' interchangeable.This decision concerned many.The decision by the CMS will lead to lower DCB utilization and limit randomized controlled trial-demonstrated superior treatment for elderly and economically disadvantaged patients due to significant cost differences accrued by vascular intervention centers.In a previously published Viewpoint, we raised major concerns and outlined the clinical evidence clearly favoring DCB over uncoated PTA. 4 However, in the July 2018 outpatient hospital rule for CY 2019, the CMS maintained their position of considering DCB and PTA in the same APC category, essentially promoting an inferior reimbursement strategy that does not value efficacy, outcomes, and cost-savings over an episode of care.The CMS has offered an 8-week open comment period so that all interested parties can express their concerns or support for the recent decision.We ask that all interested individuals provide comments on the CMS website (http:// www.regulations.gov)under search term 'CMS-1695-P'.We suggest that clinical and policy experts and researchers indicate the importance of proper reimbursement for the technology that has demonstrated the highest levels of scientific evidence in treating PAD, with multiple publications Centers for Medicare & Medicaid Services' decision on drug-coated balloons: No additional reimbursement despite higher cost and highest levels of scientific evidence
Source: Vascular Medicine
Institutions: University Hospitals of Cleveland, University Hospitals Cleveland Medical Center, Ochsner Medical Center, Vanderbilt University Medical Center, Mayo Clinic, Kaiser Permanente, Mount Sinai Health System, University of South Carolina, Palmetto Health Richland, Duke University, Massachusetts General Hospital, Duke Clinical Research Institute, Baptist Hospital of Miami, Newton Wellesley Hospital
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2891318308